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Home / GMP

GMP

White House Released Report on Growing U.S. Biomanufacturing Capacity for the American Bioeconomy
Biotechnology | CDC | FDA | Genomics | Medical Device | NIH | Non-Profit Research | Oncology | Therapeutics | U.S. Congress

White House Released Report on Growing U.S. Biomanufacturing Capacity for the American Bioeconomy

On Nov. 15, 2024, the White House Office of Science and Technology Policy released a report on Building…

Read More White House Released Report on Growing U.S. Biomanufacturing Capacity for the American BioeconomyContinue

Thermo Fisher Scientific opened cell therapy facility at University of California, San Francisco
Agriculture | Life Science History

Thermo Fisher Scientific opened cell therapy facility at University of California, San Francisco

On Mar. 27. 2023, Thermo Fisher Scientific and the University of California, San Francisco, announced they will accelerate…

Read More Thermo Fisher Scientific opened cell therapy facility at University of California, San FranciscoContinue

Oragenics engages KBI Biopharma to support development of intranasal COVID-19 vaccine candidate NT-CoV2-1
Life Science History | Vaccine

Oragenics engages KBI Biopharma to support development of intranasal COVID-19 vaccine candidate NT-CoV2-1

On Mar. 10, 2022, Oragenics announced that it had entered into an agreement with KBI Biopharma for the…

Read More Oragenics engages KBI Biopharma to support development of intranasal COVID-19 vaccine candidate NT-CoV2-1Continue

Thermo Fisher  and University of California, San Francisco announced cell therapy cGMP manufacturing and collaboration center
Life Science History

Thermo Fisher and University of California, San Francisco announced cell therapy cGMP manufacturing and collaboration center

On May 19, 2021, Thermo Fisher Scientific and the University of California, San Francisco (UCSF) announced they have…

Read More Thermo Fisher and University of California, San Francisco announced cell therapy cGMP manufacturing and collaboration centerContinue

CytoDyn submitted Most Crucial Section of interim order to Health Canada for COVID-19 under rolling review
Biotechnology | COVID-19 | Infectious Disease | Therapeutics

CytoDyn submitted Most Crucial Section of interim order to Health Canada for COVID-19 under rolling review

On Apr. 19, 2021, CytoDyn announced it had submitted the manufacturing section (CMC) of the application for an…

Read More CytoDyn submitted Most Crucial Section of interim order to Health Canada for COVID-19 under rolling reviewContinue

INOVIO expanded global manufacturing consortium for COVID-19 vaccine candidate with Kaneka Eurogentec
Biotechnology | COVID-19 | Infectious Disease | Vaccine

INOVIO expanded global manufacturing consortium for COVID-19 vaccine candidate with Kaneka Eurogentec

On Dec. 3, 2020, Inovio Pharmaceuticals announced the execution of an agreement with Kaneka Eurogentec an affiliate of…

Read More INOVIO expanded global manufacturing consortium for COVID-19 vaccine candidate with Kaneka EurogentecContinue

Rentschler Biopharma contributed to manufacturing of COVID-19 mRNA vaccine
Life Science History | Vaccine

Rentschler Biopharma contributed to manufacturing of COVID-19 mRNA vaccine

On Oct. 7, 2020, Rentschler Biopharma announced an agreement to serve as CDMO partner for BioNTech. As an…

Read More Rentschler Biopharma contributed to manufacturing of COVID-19 mRNA vaccineContinue

Bio-Techne announced opening of GMP manufacturing facility in Twin Cities
Biotechnology | Diagnostics | Therapeutics

Bio-Techne announced opening of GMP manufacturing facility in Twin Cities

On Sept. 30, 2020, Bio-Techne announced the opening of its approximately 61,000 square foot state-of-the-art GMP (Good Manufacturing…

Read More Bio-Techne announced opening of GMP manufacturing facility in Twin CitiesContinue

BioNTech acquired GMP manufacturing site to expand COVID-19 vaccine production
COVID-19 | Life Science History | Vaccine

BioNTech acquired GMP manufacturing site to expand COVID-19 vaccine production

On Sept. 17, 2020, BioNTech announced an agreement with Novartis to acquire their GMP certified manufacturing facility in…

Read More BioNTech acquired GMP manufacturing site to expand COVID-19 vaccine productionContinue

Airway Therapeutics and Celonic Group collaborated to produce AT-100 as promising new candidate for Coronavirus
Biotechnology | COVID-19 | Therapeutics

Airway Therapeutics and Celonic Group collaborated to produce AT-100 as promising new candidate for Coronavirus

On May 20, 2020, Airway Therapeutics and Celonic Group announced a collaboration to produce the novel human recombinant…

Read More Airway Therapeutics and Celonic Group collaborated to produce AT-100 as promising new candidate for CoronavirusContinue

Vaxart announced selection of its oral COVID-19 vaccine lead candidate
COVID-19 | Life Science History | Vaccine

Vaxart announced selection of its oral COVID-19 vaccine lead candidate

On May 20, 2020, Vaxart announced it had selected its lead COVID-19 vaccine candidate and had contracted with…

Read More Vaxart announced selection of its oral COVID-19 vaccine lead candidateContinue

NantKwest announced FDA authorization of IND application for mesenchymal stem cell product for treatment of severe COVID-19 patients
COVID-19 | FDA | Life Science History

NantKwest announced FDA authorization of IND application for mesenchymal stem cell product for treatment of severe COVID-19 patients

On May 18, 2020, NantKwest announced it had received authorization from the FDA for an Investigational New Drug…

Read More NantKwest announced FDA authorization of IND application for mesenchymal stem cell product for treatment of severe COVID-19 patientsContinue

Entos Pharma partnered with Precision NanoSystems to enable scalable GMP manufacturing of Fusogenix DNA COVID-19 vaccine
Biotechnology | COVID-19 | Nanotechnology | Pharmaceutical | Therapeutics | Vaccine

Entos Pharma partnered with Precision NanoSystems to enable scalable GMP manufacturing of Fusogenix DNA COVID-19 vaccine

On May 7, 2020, Entos Pharmaceuticals announced a partnership with PrecisionNanoSystems (PNI) to produce clinica lgrade vaccines and…

Read More Entos Pharma partnered with Precision NanoSystems to enable scalable GMP manufacturing of Fusogenix DNA COVID-19 vaccineContinue

HALIX entered collaboration with University of Oxford for GMP manufacturing of a COVID-19 vaccine
COVID-19 | Life Science History | Vaccine

HALIX entered collaboration with University of Oxford for GMP manufacturing of a COVID-19 vaccine

On Apr. 15, 2020, HALIX announced it had joined a consortium of partners under the guidance of the…

Read More HALIX entered collaboration with University of Oxford for GMP manufacturing of a COVID-19 vaccineContinue

VGXI established pilot mRNA manufacturing capabilities
COVID-19 | Infectious Disease | Vaccine

VGXI established pilot mRNA manufacturing capabilities

On Apr. 6, 2020, VGX announced successful implementation of new RNA production services through completion of all Phase…

Read More VGXI established pilot mRNA manufacturing capabilitiesContinue

Fosun Pharma and BioNTech formed COVID-19 vaccine strategic alliance in China
Biotechnology | COVID-19 | Therapeutics | Vaccine

Fosun Pharma and BioNTech formed COVID-19 vaccine strategic alliance in China

On Mar. 15, 2020, Fosun Pharma and BioNTech announced a strategic development and commercialization collaboration to advance BioNTech’s…

Read More Fosun Pharma and BioNTech formed COVID-19 vaccine strategic alliance in ChinaContinue

Clover and GSK announced research collaboration to evaluate Coronavirus vaccine candidate with pandemic adjuvant system
COVID-19 | Life Science History | Vaccine

Clover and GSK announced research collaboration to evaluate Coronavirus vaccine candidate with pandemic adjuvant system

On Feb. 24, 2020, Clover Biopharmaceuticals announced a research collaboration with GSK for its protein-based coronavirus vaccine candidate…

Read More Clover and GSK announced research collaboration to evaluate Coronavirus vaccine candidate with pandemic adjuvant systemContinue

Sorrento and Celularity to initiate emergency allogeneic natural killer cell therapy development for Coronavirus infection
Biotechnology | COVID-19 | Infectious Disease | Therapeutics | Vaccine | Women's Health

Sorrento and Celularity to initiate emergency allogeneic natural killer cell therapy development for Coronavirus infection

On Jan. 29, 2020, Sorrento Therapeutics announced it had initiated a clinical and manufacturing collaboration with Celularity, a…

Read More Sorrento and Celularity to initiate emergency allogeneic natural killer cell therapy development for Coronavirus infectionContinue

Just – Evotec Biologics initiated construction of first JPOD Facility in North America
Biotechnology | Therapeutics

Just – Evotec Biologics initiated construction of first JPOD Facility in North America

On Jan. 14, 2020, Evotec announced that the wholly-owned Seattle based company Just – Evotec Biologics had initiated…

Read More Just – Evotec Biologics initiated construction of first JPOD Facility in North AmericaContinue

HHS awarded $132.5 million to Sanofi Pasteur and MedImmune over five years to retrofit existing domestic vaccine manufacturing facilities
Biotechnology | Infectious Disease | Influenza | Vaccine

HHS awarded $132.5 million to Sanofi Pasteur and MedImmune over five years to retrofit existing domestic vaccine manufacturing facilities

On Jun. 14, 2007, the U.D. of Health and Human Services (HHS) awarded $132.5 million to Sanofi Pasteur…

Read More HHS awarded $132.5 million to Sanofi Pasteur and MedImmune over five years to retrofit existing domestic vaccine manufacturing facilitiesContinue

Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility
Biotechnology | FDA | Non-Profit Research | Pharmaceutical

Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility

In 2004, the Siteman Cancer Center established a Good Manufacturing Practice (GMP) facility, the first built in partnership…

Read More Siteman Cancer Center established a Good Manufacturing Practice (GMP) facilityContinue

The FDA announced the current good manufacturing practice (cGMP) initiative
FDA | Life Science History

The FDA announced the current good manufacturing practice (cGMP) initiative

On Aug. 21, 2002, the FDA announced an effort to enhance and update the regulation of manufacturing processes…

Read More The FDA announced the current good manufacturing practice (cGMP) initiativeContinue

FDA announced initiative to modernize the regulation of pharmaceutical manufacturing
FDA | Life Science History

FDA announced initiative to modernize the regulation of pharmaceutical manufacturing

On Aug. 21, 2002, the FDA announced an initiative to modernize the regulation of pharmaceutical manufacturing and product…

Read More FDA announced initiative to modernize the regulation of pharmaceutical manufacturingContinue

University of Iowa began pharmaceutical production
Biotechnology | CMO | FDA | Life Science History | Non-Profit Research | Pharmaceutical

University of Iowa began pharmaceutical production

In Jul. 1974, In the Division of Pharmaceutical Service at the University of Iowa began producing cGMP compliant…

Read More University of Iowa began pharmaceutical productionContinue

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